In Cardiology, Medical Devices Dominate Drugs

At a major conference this week, Abbott and Medtronic deliver news about heart devices.

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Medical devices are the new black at this year's annual meeting of the American College of Cardiology, which is currently taking place in Atlanta.

Products like catheters and stents have usurped heart drugs that usually take center stage at the four-day meeting, proving that the devices could be the next big growth drivers for a realm of companies. Abbott Laboratories (ABT) had analysts' hearts aflutter this weekend after it announced the results from two pivotal studies. The results of the Everest II study showed that the company's MitraClip system, a clip used to help close the mitral valve of the heart that's inserted via catheter, could be a viable alternative to more invasive valve replacement or repair surgery.

The MitraClip is meant to treat mitral regurgitation, the most common type of heart valve problem. MR occurs when the mitral valve of the heart doesn't close tightly enough and blood flows backward into the heart causing other areas of the heart to swell to compensate for the extra blood flow. The problem affects more than 8 million people in the US and Europe, creating a sizable market for a less-invasive alternative, and can lead to stroke and heart failure. Abbott expects the MitraClip to be approved in 2011 and believes it could eventually garner a market of almost $1 billion.

Leerink Swann analyst Rick Wise called the data positive, saying:

Most physicians believe that, at least initially, the MitraClip will address a niche and highly restricted patient population that is too high risk for surgery -- in line with Abbott's stated peak sales goal of a couple hundred million dollars within five years. But with more long-term data and mitral regurgitation four times more prevalent than atrial fibrillation, most physicians agreed that the MitraClip's addressable market could be significantly larger.

Despite the good feedback for its device, Abbott had a mixed bag at the conference; results for its triglyceride-lowering pill combination weren't quite as favorable as its device study. Results from the Accord study were released on Sunday, which looked at the safety and efficacy of Abbott's TriCor pill in addition to AstraZeneca's (AZN) cholesterol drug Crestor for reducing heart attack, stroke, and death among type 2 diabetes patients.

Accord showed that the combination of the two drugs didn't prevent the adverse cardiac events any better than Crestor and a placebo. The combination of the drug did have some positive cardiovascular benefits for patients who started the study with the lowest levels of HDL cholesterol and the highest levels of triglycerides.

"Overall, the results of the Accord lipid trial do not support the use of combination therapy with a fibrate and a statin to reduce cardiovascular disease in most high-risk adults with type 2 diabetes," said lead author of the study Henry N. Ginsberg, M.D., director of the Irving Institute for Clinical and Translational Research at Columbia University College of Physicians and Surgeons, New York City. "Although our analysis suggests that certain patients may benefit from combination therapy, this study provides important information that should spare many people with diabetes unneeded therapy with fibrates."

Abbott said in a press statement that the results were "widely expected" and "not surprising."

Aside from Abbott, Medtronic (MDT) has been holding analyst interest at the ACC conference. It reported positive safety and efficacy data from a study on its Arctic Front cryoblation catheter, which treats occasional episodes of irregular heartbeat. The study showed that the catheter system was more effective in treating the condition than drug therapy.

Leerink Swann estimates that the market is worth up to $600 million. The problem affects about 2.2 million Americans.

A study of the St. Jude Medical (STJ) catheter ablation system -- a device that's threaded through blood vessels until it reaches the affected tissue and then destroys the tissue -- showed that the device was more effective in treating atrial fibrillation, a rapid irregular heart rhythm, than drug therapy. The study had only 60 patients involved and is currently being followed up with a larger trial.

On the drug side, Merck (MRK) and Portola Pharmaceuticals announced mid-stage data on the blood clot prevention drug betrixaban. The drug could become a replacement for the widely-prescribed warfarin, an anticoagulant that's been known to cause bleeds.

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